Total Neoadjuvant Therapy With FOLFIRINOX Followed by Individualized Chemoradiotherapy for Borderline Resectable Pancreatic Adenocarcinoma

作者：Janet E. Murphy, Jennifer Yon-Li Wo, David P. Ryan, Wenqing Jiang, Beow Yong Yeap, Lorraine C. Drapek, Lawrence Scott Blaszkowsky, Eunice Lee Kwak, Jill N. Allen, Jeffrey William Clark, Jason Edward Faris, Andrew Xiuxuan Zhu, Lipika Goyal, Keith D. Lillemoe, Thomas F. DeLaney, Carlos Fernández‐del Castillo, Cristina Rosa Ferrone, Theodore Sunki Hong · 发表于：JAMA Oncology · 年份：2018 · DOI：10.1001/jamaoncol.2018.0329 · 被引用次数：550 · 研究领域：Pancreatic and Hepatic Oncology Research、Cholangiocarcinoma and Gallbladder Cancer Studies、Pancreatitis Pathology and Treatment

Importance: Patients with borderline-resectable pancreatic ductal adenocarcinoma have historically poor outcomes with surgery followed by adjuvant chemotherapy. Evaluation of a total neoadjuvant approach with highly active therapy is warranted. Objective: To evaluate the margin-negative (R0) resection rate in borderline-resectable pancreatic ductal adenocarcinoma after neoadjuvant FOLFIRINOX (fluorouracil, irinotecan, and oxaliplatin) therapy and individualized chemoradiotherapy. Design, Setting, and Participants: A single-arm, phase 2 clinical trial was conducted at a large academic hospital with expertise in pancreatic surgery from August 3, 2012, through August 31, 2016, among 48 patients with newly diagnosed, previously untreated, localized pancreatic cancer determined to be borderline resectable by multidisciplinary review, who had Eastern Cooperative Oncology Group performance status 0 or 1 and adequate hematologic, renal, and hepatic function. Median follow-up for the analysis was 18.0 months among the 30 patients still alive at study completion. Interventions: Patients received FOLFIRINOX for 8 cycles. Upon restaging, patients with resolution of vascular involvement received short-course chemoradiotherapy (5 Gy × 5 with protons) with capecitabine. Patients with persistent vascular involvement received long-course chemoradiotherapy with fluorouracil or capecitabine. Main Outcomes and Measures: The primary outcome was R0 resection rate; secondary outcomes were median pr...